Dosing mediNiK Hydrogel for Kidney Stone Removal Using ViscoTec Systems
Kidney stone surgery has taken a major leap forward. Purenum GmbH, a spin-off from the renowned Fraunhofer Institute for Manufacturing Technology and Advanced Materials (IFAM), has developed mediNiK – a certified two-component hydrogel that enables the removal of previously inaccessible stone fragments.
To precisely dose this sensitive, high-performance material, Purenum turned to the ViscoTec 2VPHD12-3D Hygienic Dispenser, designed for cleanroom environments and FDA/GMP compliance.
What Is mediNiK?
mediNiK is a dual-component hydrogel used during kidney stone surgery:
Component K1 (blue) flows around tiny fragments
Component K2 (yellow) triggers gelation upon contact
The formed gel binds fragments into a removable elastic mass
Afterwards, the gel is easily dissolved for stone analysis
The EU certification, granted in May 2021, makes mediNiK an approved medical device with strict production oversight.
Learn more about EU Medical Device Regulations (MDR)
Why ViscoTec Technology Was Essential
When it comes to medical-grade materials like mediNiK, hygiene, precision, and control are paramount. The team at Purenum required a solution that:
Delivers precise fill volumes (3–9 ml)
Operates in GMP-compliant cleanrooms
Connects directly to syringes via Luer Lock
Minimizes air bubbles
Allows easy disassembly, cleaning, and sterilization
According to Manfred Peschka, Managing Director at Purenum:
“By using the dispenser from ViscoTec, the syringes could be filled very effectively with mediNiK despite the small batch size.”
Clean, Flexible, and Validated Filling
The ViscoTec 2VPHD12-3D excels at small-batch, high-precision medical filling thanks to:
FDA-compliant materials
High repeat accuracy for validation under IQ/OQ protocols
Cleanroom-ready configuration
Proven adaptability to changing material properties
Learn more about GMP manufacturing principles
🇬🇧 Trusted in the UK: Capri Systec
As the official UK distributor for ViscoTec, Capri Systec offers:
Tailored semi- and fully-automatic filling systems
GMP, pharma, food, and cosmetic solutions
Experience with viscous, sensitive, and abrasive materials
End-to-end support including validation and documentation
Capri Systec supports clients in pharma, medtech, and cleanroom manufacturing who demand nothing but precision.
Contact Us Today for a consultation or system demo.